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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02485002 |
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Date of registration:
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24/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath
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Scientific title:
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Differences in Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels in Patients Undergoing Retrograde Intrarenal Surgery (RIRS) With or Without Ureteral Access Sheath (UAS) |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02485002 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Ozcan Kilic, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Selcuk University, School of Medicine, Department of Urology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Being between 18-65 years old
- Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
Exclusion Criteria:
- Patients with uncontrolled diabetes mellitus and diabetic nephropathy
- Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive
agent(s)
- Patients with chronic kidney failure who need dialysis
- Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or
much earlier
- Patients who have had pyelonephritis 3 months or much earlier
- Patients younger than 18 years or older than 65 years
- Patients who have undergone a kidney surgery within the last 3 months and have
abnormal kidney function tests
- Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone
treatment at the same session
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Urolithiasis
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Intervention(s)
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Device: RIRS with ureteral access sheath
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Device: RIRS without ureteral access sheath
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Primary Outcome(s)
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Urine NGAL level (ng/mL)
[Time Frame: Within the first 7 days after surgery (RIRS)]
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Secondary Outcome(s)
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Blood urea level (mg/dL) and creatinine level (mg/dL)
[Time Frame: Within the first 7 days after surgery (RIRS)]
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Secondary ID(s)
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SU-RIRS-UAS-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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